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Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre

NCT ID: NCT04655430

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-06-30

Brief Summary

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To determine the optimal application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Detailed Description

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Methods: The randomized double blinded clinical trial will recruit 414 healthy kindergarten children aged 3-5 years old with caries and with parental consent. The sample size is sufficient for the appropriate statistical analyses. The children will receive 0.004 mL 38% SDF (typical amount applied per manufacturer's instructions) to treat each caries lesion. The children will be classified into high and low caries rates and equably allocated into nine groups of SDF application time: 3, 5, 15, 30, 45, 60, 120 and 180 seconds. The children will be followed up for 6-months in their kindergartens. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 6-months follow-up. The examiner, the children and the children's parents will be blind to the treatment allocation. The analysis will determine the significance of differences between the means of arrested caries at the various follow-ups; and Cochran-Armitage test will be used to evaluate the exposure (SDF-application time) to response relationship.

Significance: This study will help determine the optimal application time in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Conditions

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Early Childhood Caries

Keywords

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silver diamine fluoride application time preschool children early childhood caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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3-second SDF application

3-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

3-second SDF application

Intervention Type OTHER

Dosage: 3-second 38% SDF solution application

5-second SDF application

5-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

5-second SDF application

Intervention Type OTHER

Dosage: 5-second 38% SDF solution application

10-second SDF application

10-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

10-second SDF application

Intervention Type OTHER

Dosage: 10-second 38% SDF solution application

15-second SDF application

15-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

15-second SDF application

Intervention Type OTHER

Dosage: 15-second 38% SDF solution application

30-second SDF application

30-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

30-second SDF application

Intervention Type OTHER

Dosage: 30-second 38% SDF solution application

45-second SDF application

45-second application time of silver diamine fluoride (38% SDF) in arresting tooth decay (dental caries) in the primary teeth of preschool children.

Group Type EXPERIMENTAL

45-second SDF application

Intervention Type OTHER

Dosage: 45-second 38% SDF solution application

60-second SDF application

60-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

60-second SDF application

Intervention Type OTHER

Dosage: 60-second 38% SDF solution application

120-second SDF application

120-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

120-second SDF application

Intervention Type OTHER

Dosage: 120-second 38% SDF solution application

180-second application time

180-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Group Type EXPERIMENTAL

180-second SDF application

Intervention Type OTHER

Dosage: 180-second 38% SDF solution application

Interventions

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3-second SDF application

Dosage: 3-second 38% SDF solution application

Intervention Type OTHER

5-second SDF application

Dosage: 5-second 38% SDF solution application

Intervention Type OTHER

10-second SDF application

Dosage: 10-second 38% SDF solution application

Intervention Type OTHER

15-second SDF application

Dosage: 15-second 38% SDF solution application

Intervention Type OTHER

30-second SDF application

Dosage: 30-second 38% SDF solution application

Intervention Type OTHER

45-second SDF application

Dosage: 45-second 38% SDF solution application

Intervention Type OTHER

60-second SDF application

Dosage: 60-second 38% SDF solution application

Intervention Type OTHER

120-second SDF application

Dosage: 120-second 38% SDF solution application

Intervention Type OTHER

180-second SDF application

Dosage: 180-second 38% SDF solution application

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

(a) 3-5 year old children attending the first to the third year of kindergarten; (b) free from any systemic conditions and generally healthy; (c) parents sign informed consent (d) having at least 1 tooth with cavitated dentine carious lesion.

Exclusion Criteria

* uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chun-Hung Chu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Local kindergartens

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Yan IG, Zheng FM, Sun IG, Lo ECM, Duangthip D, Chu CH. A Randomized Controlled Trial of Silver Diamine Fluoride Application Time. J Dent Res. 2025 Jun 29:220345251345801. doi: 10.1177/00220345251345801. Online ahead of print.

Reference Type DERIVED
PMID: 40583169 (View on PubMed)

Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. Effect of application time of 38% silver diamine fluoride solution on arresting early childhood caries in preschool children: a randomised double-blinded controlled trial protocol. Trials. 2022 Mar 15;23(1):215. doi: 10.1186/s13063-022-06130-1.

Reference Type DERIVED
PMID: 35292085 (View on PubMed)

Other Identifiers

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HKU20201127

Identifier Type: -

Identifier Source: org_study_id